Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma

NCT07575724 | Not Yet Recruiting Phase 2

• 1 other identifier: LN_Biopsy_2025
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, non-inferiority clinical trial aims to evaluate whether non-resection of needle biopsy tract is non-inferior to routine biopsy tract resection in terms of local recurrence in patients with primary extremity musculoskeletal sarcoma undergoing en-bloc surgical treatment. Biopsy tract resection is traditionally recommended to reduce the risk of tumor seeding; however, its benefit in reducing recurrence has not been definitively demonstrated, particularly when core needle biopsy is widely used. Also, avoiding biopsy tract resection may preserve uninvolved tissue without compromising oncologic safety. The primary objective of this study is to compare local recurrence rates between patients who undergo biopsy tract resection and those who do not. Secondary objectives include comparisons of surgical complications, functional outcomes, overall survival, and progression-free survival.

Conditions

Primary; Sarcoma

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of local recurrence at 2 years

  Local recurrence is defined as radiologically or pathologically confirmed recurrence of sarcoma at or adjacent to the primary surgical site after definitive tumor resection. The cumulative incidence of local recurrence will be estimated with death treated as a competing event.

  From the date of surgery to the date of first documented local recurrence, death, or last follow-up, assessed up to 24 months after surgery.

Secondary Outcomes (14)

• Musculoskeletal Tumor Society score

  recorded at baseline and at 3, 6, 9, 12, 15, 18, 21, and 24 months after surgery.

• Henderson failure mode

  From surgery to 24 months, assessed every 3 months

• The Patient and Observer Scar Assessment Scale

  From surgery to 24 months, assessed every 3 months

• Soft tissue reconstruction

  perioperative period

• Total surgical duration

  During the operative procedure

Study Arms (2)

tract resection group

EXPERIMENTAL

Procedure: biopsy tract resection

tract non-section group

ACTIVE COMPARATOR

Procedure: biopsy tract non-resection

Interventions

biopsy tract resection PROCEDURE

Surgeons will perform standard en-bloc tumor resection according to oncologic principles. In the biopsy tract resection group, complete biopsy tract excision is defined as en-bloc removal of the entire needle biopsy pathway, including: Skin entry site: the original puncture site on the skin surface Subcutaneous and soft tissue tract: all intervening tissues traversed by the biopsy needle Deep tract structures: any muscle, fascia, periosteum, or bone structures penetrated by the needle Intratumoral component: the terminal segment of the needle pathway within the tumor All components of the biopsy tract must be removed together with the tumor specimen.

tract resection group

biopsy tract non-resection PROCEDURE

Surgeons will perform standard en bloc tumor resection in accordance with oncologic principles. In the non-resection group, the needle biopsy tract will not be intentionally excised. The biopsy tract, including the skin entry site and intervening soft tissue pathway, will be preserved unless it lies within the planned tumor resection field. If any portion of the biopsy tract is located within the standard oncologic resection field required to achieve negative margins, it will be removed as part of the tumor specimen; however, no additional resection will be performed specifically to excise the biopsy tract.

tract non-section group

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of primary bone or soft tissue sarcoma of the extremities (or highly suspected sarcoma);
• Candidate for limb-sparing surgery and capable of en-bloc resection;
• Age ≥ 5 years;
• ECOG performance status 0-2;
• Able to understand and sign informed consent.

You may not qualify if:

• Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions;
• Patients deemed, based on preoperative multidisciplinary team (MDT) evaluation, unlikely to achieve adequate surgical margins and therefore only eligible for debulking or palliative surgery;
• Patients with inconclusive needle biopsy results requiring open biopsy for definitive diagnosis;
• Patients requiring amputation;
• Patients who have received prior treatment for the tumor at non-participating centers;
• Patients with an expected survival of less than 2 years;
• Patients in whom the biopsy tract completely lies within the planned tumor resection field;
• Patients who refuse to provide written informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 311200, China

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Nong Lin, MD

CONTACT

13958195545; linnong@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2033
• Last Updated: May 8, 2026

Record last verified: 2025-11

Locations

CN (1)